SPECIAL NOTICE
A -- Cooperative Research and Development Agreement (CRADA) Opportunity for Evaluating an Influenza A/H1N1 Challenge Virus
- Notice Date
- 11/15/2012
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-OTD-2012-002
- Archive Date
- 1/18/2013
- Point of Contact
- Maryann T. Puglielli, Ph.D., J.D., Phone: 3015946656
- E-Mail Address
-
maryann.puglielli@nih.gov
(maryann.puglielli@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SUMMARY: The National Institutes of Health (NIH) is announcing an opportunity for a Cooperative Research and Development Agreement (CRADA) for evaluating an Influenza A/H1N1 Challenge Virus developed at the National Institute of Allergy and Infectious Disease (NIAID) in a clinical setting for the purposes of drug and vaccine development. The NIAID seeks to enter into a CRADA with one or more biotechnology or biomedical companies to evaluate the utility of an Influenza A/H1N1 Challenge Virus developed by NIAID for the purposes of developing influenza drug treatments or vaccines. SUPPLEMENTARY INFORMATION: The high seasonal morbidity and mortality associated with both pandemic and seasonal influenza, the continued threat of highly pathogenic avian influenza infections, the development and global spread of antiviral resistance, and the need to plan for future influenza pandemics makes influenza a high priority in infectious disease research. Indeed, approximately 30,000 people die each year from complications due to influenza infection in the U.S. alone. Because animal models of influenza are limited in their ability to replicate human disease, new drug development and the search for better vaccines and vaccine strategies is ongoing and will require significant clinical development. Moreover, many important questions about influenza infection can only be approached through human studies of influenza. In an effort to facilitate these clinical studies, NIAID has developed the Influenza A/H1N1 Challenge Virus, which is a reverse genetics produced, cell cultured wild-type A(H1N1)pdm09 influenza virus for use in healthy volunteers under an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). NIAID plans to use its method of reverse genetics and cell culture to produce additional influenza strain preparations for use in human studies. The Influenza A/H1N1 Challenge Virus stands to streamline and reduce the cost of evaluating candidate vaccines and treatments. Specifically, clinical studies of influenza are expensive and inefficient due to the large numbers of subjects needed to determine efficacy of a new treatment or vaccine, and they are limited in their ability to provide standardized data due to the lack of our ability to identify the timing of viral exposure and development of disease. This inhibits the success of studies and an investigator's ability to evaluate efficacy as well as to study the natural history and pathogenesis of this global disease. Once infection with this challenge virus is characterized in healthy human volunteers, the number of volunteers needed for subsequent efficacy studies will be smaller and the resulting data more informative. With regard to improving the understanding of influenza infection and the resulting immune response in humans, previous human challenge studies have been used to address some aspects of influenza related illness by evaluating the timing of viral replication, shedding, clinical symptoms, and innate and adaptive immune response. They also proved extraordinarily useful in the development of currently available antivirals. Although the influenza research community clearly identifies a need for these types of studies, in the United States all but 1 published study were performed prior to 1990, and all had limitations due to the scope of the study or the scientific techniques that were available at the time. Currently, no virus for the purpose of study in healthy volunteers is available in the U.S. and these studies are not being performed. The NIAID Influenza A/H1N1 Challenge Virus will be used to start a program of clinical influenza studies to initially characterize this virus preparation in healthy volunteers. A validated model of infection in these volunteers will allow more efficient and cost-effective phase II clinical development of antivirals and vaccines, as noted above, as well as an opportunity to study correlates of protection and the natural history and pathogenesis of influenza in a controlled setting. Timing of exposure will be known, a standard dose used, and many other potentially confounding variables can be controlled. A CRADA is the anticipated collaborative agreement to be entered into with NIAID pursuant to the Federal Technology Transfer Act of 1986, codified as 15 U.S.C. 3710a, and Executive Order 12591 of April 10, 1987, as amended. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government entities. A CRADA is not a grant, and it is not a contract for the procurement of goods and services. The NIAID is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, NIAID can contribute facilities, staff, materials, and expertise. The CRADA collaborator can contribute facilities, staff, materials, expertise, and funds. The CRADA collaborator will also have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, diagnostics, and treatments that result from the research. CRADA partners are currently being sought to evaluate the utility of the NIAID Influenza A/H1N1 Challenge Virus in a clinical setting for the purposes of drug and vaccine development. These clinical trials will be performed at the NIH Clinical Center. Studies will be designed (1) to meet the specific efficacy testing needs of each individual product under investigation and (2) to further the investigation of influenza related disease. NIAID's clinical principal investigator has extensive experience with running clinical studies of human influenza, working with animal models of influenza, and both classic and molecular virology studies. This principal investigator also has expertise in the area of antiviral resistance and influenza infections in at risk individuals and populations. EVALUATION CRITERIA: CRADA partners will be expected to have their drug or vaccine well characterized, to have Phase I testing complete, and to have the drug or vaccine approved under an FDA IND prior to clinical studies beginning with the NIAID Influenza A/H1N1 Challenge Virus. In addition, it will be expected that the collaborator would provide funding to supplement the NIAID clinical principal investigator's budget to support this project. Prospective CRADA partners are expected to provide a written Capability Statement to the contact person indicated in this announcement prior to consideration by NIAID. The Capability Statement must address, with specificity, each of the following selection criteria: (1) a description of the partner's influenza vaccine or therapeutic and its IND status; (2) results of Phase I testing of the vaccine or therapeutic; and (3) ability to perform supporting tests (i.e., immunological testing) relevant to the study; (4) the technical expertise of the partner's Principal Investigator and laboratory group; and (5) the ability to provide adequate and sustained funding to support performance of the research plan throughout the life of the CRADA. NIAID will consider executing a Confidentiality Agreement with a prospective CRADA partner to facilitate receipt of the Capability Statement if requested by a prospective CRADA partner.
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